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# Roche Cobas Malaria Test Approved
- URL: https://www.fdaweb.com/roche-cobas-malaria-test-approved/
- Published: 2024-03-29T12:00:00.000Z
- Updated: 2026-09-14T14:26:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156665

FDA has approved Roche’s cobas malaria test for use on the cobas 6800/8800 Systems to aid healthcare professionals in reducing potential risks of patient infection from transfused blood products. The test provides a “highly sensitive and specific solution to help ensure that infected blood units are removed from the blood supply,” the company says, adding that it screens whole blood samples for the five main species of *Plasmodium* parasites that are known to cause human infection. The test is intended for use in screening blood, organ and tissue donors.

The qualitative *in vitro* nucleic acid screening test allows for direct detection of *Plasmodium* RNA and DNA in whole blood samples from individual human donors, the company says. It can be performed with other routine blood donor screening tests on the cobas 6800/8800 Systems in the U.S. “The test is not intended for use to diagnose *Plasmodium* infection, for use on cord blood samples or for use on cadaveric blood specimens,” it adds.